FDA 483 - Natco Pharma Ltd. - Chemical Division - August 09, 2019

An FDA inspection of Natco Pharma Limited, an Active Pharmaceutical Ingredients manufacturer in Rangareddy District, India, revealed significant deficiencies across multiple quality systems. Observations included inadequate quality control procedures, insufficient employee training, lack of process revalidation after critical changes, and poor equipment cleaning and maintenance. Additionally, issues with computer system controls and laboratory practices for microbial testing were noted, indicating a broad failure to ensure product quality and purity.